Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients

• Published in: BMC medicine Vol. 14; no. 1; p. 128
• Main Authors: Cubiella, Joaquín, Vega, Pablo, Salve, María, Díaz-Ondina, Marta, Alves, Maria Teresa, Quintero, Enrique, Álvarez-Sánchez, Victoria, Fernández-Bañares, Fernando, Boadas, Jaume, Campo, Rafel, Bujanda, Luis, Clofent, Joan, Ferrandez, Ángel, Torrealba, Leyanira, Piñol, Virginia, Rodríguez-Alcalde, Daniel, Hernández, Vicent, Fernández-Seara, Javier
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 31-08-2016; BioMed Central
• Subjects: Aged; Biochemical markers; Biomarkers - analysis; Cancer; Carcinoembryonic Antigen - analysis; Colonoscopy; Colonoscopy - methods; Colonoscòpia; Colorectal cancer; Colorectal Neoplasms - diagnosis; Colorectal Neoplasms - pathology; Cross-Sectional Studies; Càncer colorectal; Diagnosis; Diagnòstic; Early Detection of Cancer - methods; Feces; Female; Hemoglobins - analysis; Humans; Immunochemistry; Immunochemistry - methods; Leukocyte L1 Antigen Complex - analysis; Male; Marcadors bioquímics; Marcadors tumorals; Medical protocols; Methods; Models, Theoretical; Predictive Value of Tests; Prognosis; Pronòstic mèdic; Prospective Studies; Protocols clínics; Risk Assessment - methods; Testing; Tumor markers; Spain; Prompt diagnosis; Colonoscopy; Diagnostic accuracy; Colorectal cancer; Faecal immunochemical test; Risk stratification
• DOI: 10.1186/s12916-016-0668-5
• EISSN: 1741-7015

Risk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables.
This prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome.
We included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02-1.06), male gender (OR 2.2, 95 % CI 1.5-3.4), faecal haemoglobin ≥20 μg/g (OR 17.0, 95 % CI 10.0-28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2-10.3), blood haemoglobin 10-12 g/dL (OR 1.8, 95 % CI 1.1-3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0-6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2-0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06-0.2), rectal mass (OR 14.8, 95 % CI 5.3-41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2-0.4), rectal bleeding (OR 2.2, 95 % CI 1.4-3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1-2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91-0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55-0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7-45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8-6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0-1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90-0.94; p = 0.7).
COLONPREDICT is a highly accurate prediction model for CRC detection.